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safescimet course 5.1 - Clinical Safety: Pre-Approval

The clinical phase during drug development requires translation of safety information from previous pre-clinical trials of the new compound. Signal detection depends on the understanding of mechanisms of action, preclinical safety findings including histopathology and the monitoring of applicable baseline biomarkers. The translation of animal findings regarding toxicity levels and target organs to human has to ensure a safe First Dose in Man where appropriate risk mitigation strategies play major roles. Therefore the aim of this course is to introduce the principles of translational safety as a tool to bridge preclinical and clinical safety assessments as well as safety management throughout the clinical phase of drug development. Lecturers and students will discuss the strengths and limits of these approaches and will have insight into the overall strategy of clinical safety evaluation prior to drug approval. Case studies from the development of successful new drugs as well as from discontinued compounds are used to illustrate the process of developing safe medicines. Also regulatory requirements from the major target markets are presented and discussed. Upon completion of the course the students will have an overall understanding of integrated drug safety activities, how to approach safety margins during translation from animal to man and the benefit / risk assessment methodology used during drug development.